Application 078969

Type: ANDA
Sponsor: NATCO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078969-001	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2009-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078969-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078969-001	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2009-06-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078969-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078969-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078969-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078969-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078969-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078969-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078969-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078969-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078969-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078969-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078969-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078969-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078969-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078969-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078969-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078969-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078969-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078969-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078969-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078969-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078969-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078969-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078969-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078969-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078969-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078969-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078969-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078969-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078969-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078969-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078969-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078969-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078969-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078969-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078969-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078969-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078969-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078969-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078969-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078969-001	AB	1	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Granisetron Hydrochloride	GRANISETRON HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	df4b6775-4337-41e0-815a-b064d98c3fe1	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078969 application number: ANDA078969 ndc (product): 51991-735
Granisetron hydrochloride	GRANISETRON HYDROCHLORIDE	Natco Pharma Limited	d2be8de3-04fe-4e92-82b4-98d749b89596	2019-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078969 application number: ANDA078969 ndc (product): 63850-0005

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51991-735	Granisetron Hydrochloride	Granisetron Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-735	Granisetron Hydrochloride	Granisetron Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-735	Granisetron Hydrochloride	Granisetron Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-735	Granisetron Hydrochloride	Granisetron Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
63850-0005	Granisetron hydrochloride	Granisetron hydrochloride	Natco Pharma Limited	ANDA	Current
67877-184	Granisetron Hydrochloride	Granisetron Hydrochloride	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53914	ORIG	2018-05-01